FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K Number: K040501
·
Decision Apr 29, 2005
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
24
Review Days
428
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Basic Information
- Device Name
- DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
- K Number
- K040501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Musculoskeletal Transplant Foundation
- Date Received
- February 26, 2004
- Decision Date
- April 29, 2005
- Product Code
- NUN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUN | Bone Grafting Material, Human Source | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUN), ordered by most recent decision date.
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
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Other Clearances by Musculoskeletal Transplant Foundation
| K Number | Device Name | ||
|---|---|---|---|
| K181633 | MTF Pre-Sutured Tendon | Mar 15, 2019 | Substantially Equivalent |
| K121313 | MTF NEW BONE VOID FILLER | Jan 11, 2013 | Substantially Equivalent |
| K120479 | MTF FASCIA | Nov 8, 2012 | Substantially Equivalent |
| K113167 | MTF NEW BONE VOILD FILLER | Jan 24, 2012 | Substantially Equivalent |
| K110003 | MTF NEW BONE VOID FILLER | Oct 13, 2011 | Substantially Equivalent |
| K103795 | DBX DEMINERALIZED BONE MATRIX PUTTY | Apr 13, 2011 | Substantially Equivalent |
| K103784 | DBX DEMINERALIZED BONE MATRIX PUTTY | Apr 13, 2011 | Substantially Equivalent |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Oct 2, 2009 | Substantially Equivalent |
| K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | Sep 28, 2009 | Substantially Equivalent |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Oct 10, 2008 | Substantially Equivalent |